Roswell, GA, United States
AZIYO BIOLOGICS recalls
1 recall recorded since 2018, most recently on 21 August 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 21 August 2019
- Terminated
- 17 September 2020
- Reason
- Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
- Distribution
- US Nationwide distribution including the states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, LA, MI, MN, MO, MS, NC, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0039-2020, Z-0040-2020
- BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope
- CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Enve
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.